Dissemination and Implementation of the SPRINT Study Findings in Underserved Populations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,272
- 试验地点
- 4
- 主要终点
- Difference in a fidelity summary score for key implementation strategy components during the 18-month intervention.
研究概览
简要总结
The IMPACTS study utilizes an effectiveness-implementation hybrid type 2 design to achieve two primary goals simultaneously: 1). to test the effectiveness of a multifaceted implementation strategy for intensive BP control among underserved hypertensive patients at high risk for CVD, and 2). to assess the implementation outcomes of the multifaceted implementation strategy in patients and providers.
详细描述
Recently, the Systolic Blood Pressure Intervention Trial (SPRINT) reported that more intensive blood pressure (BP) treatment (target systolic BP<120 mm Hg) reduced major cardiovascular disease (CVD) by about 25% and all-cause mortality by about 27% compared to standard BP treatment (target systolic BP<140 mm Hg) among hypertensive patients aged ≥50 years. SPRINT clearly answered the question - Will lowering BP more than the currently recommended goal further reduce the risk of CVD and mortality? The next important question is how to implement a more intensive BP treatment program in real-world clinical practice, especially in underserved patients. The IMPACTS trial is an effectiveness-implementation hybrid trial to simultaneously test the effectiveness of a multicomponent intervention program for more intensive BP treatment and the feasibility and fidelity of implementing the program in underserved patients with hypertension in Louisiana and Mississippi. The Consolidated Framework for Implementation Research has been used to guide the development of the multicomponent intervention, including dissemination of SPRINT study findings among patients, providers and policymakers; team-based collaborative care using a stepped-care protocol adapted from the SPRINT intensive-treatment algorithm, BP audit and feedback, and home BP monitoring; and health coaching on antihypertensive medication adherence and lifestyle modification. The investigators will collaborate with 36 federally qualified health center clinics that serve low-income populations in Louisiana and Mississippi to recruit 1,260 trial participants and conduct the IMPACTS trial. The primary clinical outcome is the difference in mean change of systolic BP from baseline to 18 months. The fidelity of the intervention, measured by intensification of treatment by providers and adherence to medications in patients, will be the primary implementation outcome. This study will generate urgently needed data on effective and adoptable intervention strategies aimed at eliminating health disparities and reducing the BP-related disease burden in underserved populations in the US.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Difference in a fidelity summary score for key implementation strategy components during the 18-month intervention.
时间窗: Baseline to 18 months
A fidelity summary score includes adherence to antihypertensive medications, initiation or intensification of treatment, home BP monitoring, and health education over the intervention period. The fidelity summary score ranges from 0 (worst) to 4 (best)
Difference in mean change of systolic BP
时间窗: Baseline to 18 months
The primary outcome is the difference in mean change of systolic blood pressure from baseline to 18 months between intervention and control groups. Blood pressure will be measured 3 times each at two baseline, one 6-month, one 12-month, and two termination visits according to a standard protocol.
次要结局
- Acceptance to intensive BP target by providers in intervention clinics(Baseline to 18 months)
- Adherence to clinical appointments in the intervention group(Baseline to 18 months)
- Proportion of patients with systolic blood pressure <130 mm Hg(Baseline to 18 months)
- Intensification of treatment (fidelity)(Baseline to 18 months)
- Self-reported health education at previous clinic visits (fidelity)(Baseline to 18 months)
- Difference in mean change of diastolic blood pressure(Baseline to 18 months)
- Proportion of patients with systolic blood pressure <120 mm Hg(Baseline to 18 months)
- Health-related quality of life (SF-12)(Baseline to 18 months)
- Medication adherence (fidelity)(Baseline to 18 months)
- Self-reported home BP monitoring (fidelity)(Baseline to 18 months)
- Proportion of patients with a >30 mm Hg reduction in systolic blood pressure(Baseline to 18 months)
- Satisfaction with antihypertensive medications(Baseline to 18 months)
- Satisfaction with BP-related care(Baseline to 18 months)
- Adherence to health coach session in the intervention group(Baseline to 18 months)
研究者
Jiang He, MD, PhD
Professor and Director
Tulane University